Kornimate/medical-research-clean huggingface dataset:
urological deterioration in secondary tethered cord syndrome and clue to detect it

Conditions: Neurogenic Bladder; Tethered Spinal Cord Syndrome

Summary: secondary tethered cord syndrome (stcs) has been diagnosed with signs of progressive deterioration in urological or neuroorthopedic systems following primary tethering surgery. however, there is no convincing urological diagnostic clue for stcs.

tethered cord syndrome (tcs) refers to various problems involving neurologic, orthopedic, and urologic systems, seen as a result of chronic traction of the spinal cord in patients with spinal dysraphism. evidence for neural injury is often assumed irreversible, so untethering is justified to maintain neural function and prevent further neural damage. unfortunately, some patients experienced an aggravation of symptoms following untethering. the probable causes are assumed to be the neural injury before or during operation, which was revealed along with dysplastic neural function, neural compression by increasing syrinx and secondary tethered cord syndrome (stcs) in which postoperative neural adhesion or syrinx limit motion of spinal and elicit ischemic changes as the spine grows during puberty. the secondary tethered cord syndrome is reported as 19% of cases and causes significant progressive morbidities in those who affected. unfortunately, the detection of stcs is not as simple as it thought. although magnetic resonance imaging (mri) often reveals that the cord seems to get straightened, this does not necessarily mean that is a significant tethering or cord associated with progressive nerve damage. the variable course of progression and involvement of multiple systems such as lower extremity, bladder, bowel, and back would not allow a single specialist to draw conclusions about the presence of secondary tethered cord syndrome. moreover, the untethering procedure of stcs may not always be safe and effective. given the fact that a significant number of 'no improvement' or new onset complications following redo-untethering, the surgery could not be attempted without clear evidence. this explains the reason there is only a limited number of relevant studies so far. in this study, it aims to delinate the genuine features of secondary tethered cord syndrome by selecting and analyzing only cases with symptom improvements. furthermore, it described their natural history and time course of urological deterioration and characterized by the urodynamic changes before and after the redo-untethering.

Eligibility criteria:
inclusion criteria: - children with signs of progressive deterioration in urological or neuroorthopedic system following primary untethering surgery. exclusion criteria: - children without signs of progressive in urological or neuroorthopedic system following primary untethering surgery.
car-t cells targeting autoimmune diseases

Conditions: Autoimmune Diseases

Summary: the purpose of this study is to assess the feasibility, safety and efficacy of car-t cell therapy in patients with autoimmune disease. another goal of the study is to learn more about the safety and function of the car-t cells and their persistency in autoimmune disease patients.

autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs. at present, the pathogenesis of various autoimmune diseases is still not well understood, but an imbalanced immune tolerance plays a key role in this process. an ideal therapy to autoimmune disease should eradicate pathogenic autoimmune cells but retain the protective immunity. the chimeric antigen receptor-modified t (car-t) cell technology has proven to be highly effective in targeting b cell malignancies, and the treatment-induced b cell and antibody deficiencies have implications for treating autoantibody-related autoimmune diseases. studies have shown that car-t cells targeting b cell surface molecules can kill autoreactive b lymphocytes in pemphigus vulgaris (pv) and systemic lupus erythematosus (sle) patients. thus, car-t cell technology targeting b cells has potential in treating autoimmune diseases including pv, sle, autoimmune hemolytic anemia, sjogren's syndrome etc.. cd19-specific car is based on activation of intracellular signalijng domains of t cells by the extracellular single chain variable fragment (scfv) antibody against cd19. the activated car-t cells can target and kill b cells. the investigation plans to use genetically modified t cells to express a 4th generation lentiviral anti-cd19 car with an inducible caspase 9 self-withdrawal gene (4scar) to increase the safety of this specific approach. besides targeting cd19, specific cars targeting other b cell surface molecules including bcma, cd138, and baff-r will also be included in the treatment regimen. based on accumulated experiences, the 4scar t cells have shown high safety profile without serious cytokine release syndrome (crs) or neural toxicities in patients. through this trial, the safety and long term efficacy of the b cell-specific 4scar t cell therapy will be evaluated, providing clinical evidence supporting the application of 4scar-t cell technology in the treatment of autoimmune diseases.

Eligibility criteria:
inclusion criteria: 1. age older than 18 years. 2. expression of b cell surface molecules. 3. the kps score over 80 points, and survival time is more than 3 months. 4. greater than hgb 80 g/l. 5. no contraindications to blood cell collection. exclusion criteria: 1. accompanied with other active diseases and difficult to assess treatment response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with hiv. 4. active hbv or hcv infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed car-t treatment.

Keywords: car-t autoimmune disease autoantibody cd19 bcma cd138 baff-r
prima pfo migraine trial

Conditions: Migraine; Migraine With Aura; Patent Foramen Ovale; PFO

Summary: the purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (pfo, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

the purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (pfo, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Eligibility criteria:
inclusion criteria: * subjects who are age 18 to 65 * subjects who have migraine headaches with aura diagnosed by a doctor * subjects who have not responded to or cannot take common migraine preventive medications exclusion criteria: * subjects with a clinical history of stroke * subjects who cannot take aspirin and clopidogrel (plavix) * subjects who are pregnant or desire to become pregnant within the next year

Keywords: migraine migraine with aura patent foramen ovale pfo
heart-focused anxiety in patients with heart failure and icd

Conditions: Heart Failure Patients Before and After ICD Implantation

Summary: the aim of the present study is to measure heart-focused anxiety, general anxiety, depression, ptsd and quality of life as well as type d personality in patients with heart failure before and after the implantation of a cardioverter defibrillator (icd) and/or assist device (ad).

in patients with heart failure and implantable cardioverter defibrillator (icd) psychological comorbidities such as heart focused anxiety and depression often occur. these psychological factors may have negative effects on compliance as well as on the development of the cardiac disease and therefore on rehospitalization and mortality rates. a personality structure where negative affect is paired with social inhibition (the inability to communicate ones feelings to others) can often be found in patients with cardiovascular disease. this so-called type d personality is also associated with a worse prognosis. it is of interest whether, and if so in what way, the implantation of an icd can affect the psychological well-being and through that the prognosis of the heart failure patient. the goal of this study is therefore to investigate the effect of icd implantation on heart-focused anxiety, depression, possible traumatization and quality of life in patients with heart failure with consideration of a possible moderating effect of the type d personality. furthermore, the impact of the above stated psychological factors on rehospitalization and mortality, as well as on frequency of shocks shall be examined. vice versa, the frequency of shocks or the impact of being shocked at all on psychological factors is of interest.

Eligibility criteria:
inclusion criteria: * heart failure, indication for an implantable cardioverter defibrillator exclusion criteria: * psychosis; advanced dementia; drug abuse
ptcy and ruxolitinib gvhd prophylaxis in myelofibrosis

Conditions: Primary Myelofibrosis; Myeloproliferative Disorders

Summary: a number of groups have demonstrated very low incidence of acute and chronic graft-versus-host disease (gvhd) with post-transplantation cyclophosphamide (ptcy) in haploidentical and unrelated allogeneic stem cell transplantation (sct). still the relapse of the underlining malignancy is a problem after this prophylaxis. ruxolitinib is currently one of the most promising drugs in the treatment of steroid-refractory gvhd. on the other hand, its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib before allogeneic sct might improve the outcome. this pilot trial evaluates whether the combination of ptcy and ruxolitinib facilitates adequate gvhd control, and decreases the risk of graft failure and disease progression in myelofibrosis patients.


Eligibility criteria:
inclusion criteria: * patients must have an indication for allogeneic hematopoietic stem cell transplantation * diagnosis: primary myelofibrosis secondary myelofibrosis * signed informed consent * matched related, 8-10/10 hla-matched unrelated or haploidentical donor available. the hla typing is performed by the following genetic loci: hla-a, hla-b, hla-cw, hla-drb1, and hla-dqb1. * no second tumors * no severe concurrent illness exclusion criteria: * moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50% * moderate or severe decrease in pulmonary function, fev1 \<70% or dlco\<70% of predicted * respiratory distress \>grade i * severe organ dysfunction: ast or alt \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits * creatinine clearance \< 60 ml/min * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign informed consent

Keywords: myelofibrosis ruxolitinib cyclophosphamide immunosuppressive agents immune system diseases busulfan fludarabine antineoplastic agents, alkylating myeloablative agonists hematopoietic stem cell transplantation allogeneic
enhancing medication-based analgesia in humans

Conditions: Pain; Cannabis; Opioid Use, Unspecified

Summary: this is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the fda-approved cannabinoid dronabinol (marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the fda-approved opioid hydromorphone (dilaudid).

this was a human laboratory systematic examination of whether adding the fda-approved cannabinoid dronabinol (marinol; oral) to the fda-approved opioid hydromorphone (dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. subjects are healthy individuals with no history of drug use disorder. study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. all participants completed all sessions. sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.

Eligibility criteria:
inclusion criteria: * aged 18-75 * urine sample tests negative for common illicit substances of abuse, including cannabis * medically cleared to take study medications * are not pregnant or breast feeding * willing to comply with the study protocol. exclusion criteria: * meet dsm-5 criteria for alcohol/substance use disorder * taking opioids for pain * previous adverse reaction to a cannabinoid product * prescribed and taking stimulants or benzodiazepines * answer "yes" to item 1 of the brief pain inventory indicating chronic pain * self-report any illicit drug use in the past 7 days * presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event * history of seizure disorder * have a known allergy to the study medications or sesame seed oil * taking medications contraindicated with hydromorphone or dronabinol * have a history of clinically significant cardiac arrhythmias or vasopastic disease * have an abnormal and clinically-significant ecg

Keywords: clinical trial, phase ii analgesia abuse potential
study of leukocyte populations in patients with chronic inflammatory

Conditions: Systemic Autoimmune Disease; Chronic Inflammatory Rheumatism; Sjogren's Syndrome; Spondyloarthritis; Rheumatoid Arthritis; Systemic Lupus Erythematosus

Summary: exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.

the primary objective is to characterization of the quantitative and qualitative specificities of the different leukocyte sub-populations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases. we will perform an exploratory descriptive study whom primary endpoint will be to assess by facs the phenotype of the specific leukocyte subsets. in addition, we will characterize the protein and transcriptomic signature associated with the conditions for which we have obtained preliminary data showing their potential involvement in autoimmunity (i.e: il7 pathway, ifn signature).

Eligibility criteria:
inclusion criteria: * age ≥18 years * patient who did not express his opposition * patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases (pss, lupus, scleroderma, myositis, unclassified connectivitis) diagnosed according to the usual criteria. * weight\> 35 kg exclusion criteria: * corticosteroid treatment\> 10 mg / day * pregnant patient * patients under legal protection * beneficiary of the state medical aid

Keywords: leukocytes macrophages lymphocytes rare systemic autoimmune diseases chronic inflammatory rheumatism
comparison of usg- guided modified pectoral nerve block and erector spinae plane block on postoperative analgesia in video assisted thoracoscopic surgery

Conditions: Postoperative Analgesia; Video-assisted Thoracoscopic Surgery

Summary: this study aims to compare the effects of the erector spinae plan block (esp) and modified pectoral nerve block (pecs ii) on postoperative analgesia in patients undergoing video- assisted thoracoscopic surgery (vats).

55 patients (asa i-ii-iii) between 18 and 65 years of age, who were to undergo vats, were randomized and divided into two groups. (26 patients in each of the pecs and esp groups). three patients were excluded from the study because thoracotomy was performed. esp block was performed for esp group and a modified pectoral nerve block was performed in the pecs group. postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. perioperative remifentanil use, numeric rating scale values, time of the first analgesic request, and additional analgesic consumption were recorded.

Eligibility criteria:
inclusion criteria: * ages of 18-65 * patients who will undergo vats * asa i-ii-iii patients exclusion criteria: * clinically diagnosis of spinal or chest wall deformity or pathology * clinically known local anesthetic allergy * morbid obesity (body mass index\>40 kg m2) * clinically diagnosis of opioid, alcohol and substance dependence * clinically diagnosis of psychiatric disease * coagulopathy * patients with asa iv-v
intervention with cerebral embolic protection in tevar: gaseous protection

Conditions: Stroke; Silent Cerebral Infarction; Neurocognitive Dysfunction; Vascular Brain Injury

Summary: vascular brain infarction (vbi) occurs in 67% of patients undergoing tevar. overt stroke occurs in 13% of these patients and 88% of patients suffer from neurocognitive impairment. cerebral air embolisation during the stent-graft deployment phase of tevar may be a cause of vbi. standard treatment to de-air stent-grafts is through the use of a saline flush. this study aims to investigate whether carbon-dioxide or saline is the better fluid to de-air tevar stent-grafts prior to insertion in to the patient and compare vbi rate in the carbon-dioxide group and saline group.

thoracic endovascular aortic repair (tevar) is the re-lining of the thoracic aorta to prevent life threatening haemorrhage and death from rupture. this involves a small cut in the femoral artery in the groin and under imaging guidance, the insertion of wires and a stent into the thoracic aorta. prior to insertion into the patient, stents are flushed with saline to remove air and prevent air reaching the brain that can cause a form of brain injury known as vascular brain infarction (vbi). however, our preliminary clinical data suggests that saline flushing is not effective at de-airing stent-grafts used in tevar. carbon-dioxide has been used extensively in cardiac surgery to displace air from the chest cavity to prevent peri-procedural cerebral air embolisation. we hypothesise that flushing the stent-grafts with carbon-dioxide may be better at removing air from the stent-grafts than saline flush. patients undergoing tevar will be approached to participate in this study. after written consent is obtained, participants will be randomised to undergo (tevar) with carbon dioxide or saline flushing of stent-grafts. pre-operatively, participants will undergo extensive neurocognitive testing, and a baseline blood test. intra-operatively, participants will undergo continuous transcranial doppler monitoring (tcd) of the middle cerebral artery (mca) to look for cerebral air embolisation at stent-graft deployment phase of tevar. blood testing pre-op, immediately post op, and 24 hours post op will be taken to measure for biomarkers of brain injury. post-operatively, participants will undergo another diffusion-weighted brain mri within 72 hours post-procedure, stroke and delirium assessment at day 1, 3 and day 7 +/- day of discharge, and at 6-weeks and 6-month follow-up.

Eligibility criteria:
inclusion criteria: * all participants suitable for tevar with capacity to consent exclusion criteria: * participants who lack capacity to consent * contraindications to mri such as pacemaker * pregnant participants * participants who do not wish to participate * participants \<18yrs

Keywords: stroke silent cerebral infarction carbon dioxide thoracic endovascular aortic repair tevar dw-mri vascular brain infarction
safety study of multiple peptide vaccine to esophageal cancer

Conditions: Esophageal Cancer

Summary: this is a phase 1 study of multiple peptide vaccine therapy and gm-csf in treating patients with esophageal cancer.

ly6k (lymphocyte antigen 6 complex, locus k) was identified as a new target of tumor associated antigen using cdna microarray technologies combined with the expression profiles of normal and cancer tissues. on the other hand, anti-angiogenic therapy is now considered to be one of promising approaches to treat of cancer. in this clinical trial, we evaluate the safety and immune responses of multiple peptide cocktail including ly6k and vascular endothelial growth factor receptor 1 (vegfr1) and vascular endothelial growth factor receptor 2 (vegfr2) together with ifa and gm-csf as immunoadjuvants in patients who had ly6k expressed primary esophageal cancer. toxicity profiles will be monitored, and antigen specific t cell responses will be described.

Eligibility criteria:
inclusion criteria: 1. patients must have metastatic disease of esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy 2. who performance status of 0 to 2 3. age ≥ 20 years, ≤75 years 4. chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry 5. expected survival of at least 3 months 6. wbc≥ 2,000/mm³ platelet count ≥ 100,000/mm³ total bilirubin ≤ 1.5 x the institutional normal upper limits ast, alt, alp ≤ 2.5 x the institutional normal upper limits creatinine ≤ 1.5 x the institutional normal upper limits 7. patients must be hla-a2402 8. primary lesion of esophageal cancer must express ly6k 9. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) 2. breastfeeding 3. serious infections requiring antibiotics 4. patient with peptic ulcer disease 5. previous history of intestinal perforation 6. bleeding disorders (inr ≥ 1.5) 7. necessity of drug-mediated inhibition with platelet function 8. taking antithrombogenic agents within 10 days 9. serious hypertension 10. previous history of arterial thrombosis or venous thrombosis 11. other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ 12. clinically significant heart disease or previous history of myocardial infarction within the past 12 months 13. concomitant treatment with steroids or immunosuppressing agent 14. disease to the central nervous system 15. decision of unsuitableness by principal investigator or physician-in-charge